510(k) K213521

Nihon Kohden NKV-330 Ventilator System by Nihon Kohden Orangemed, Inc. — Product Code MNT

K213521 is an FDA 510(k) premarket notification submitted by Nihon Kohden Orangemed, Inc. for the device "Nihon Kohden NKV-330 Ventilator System". The FDA issued a decision of Substantially Equivalent on July 1, 2022. The device falls under product code MNT (Sv70 Ventilator), a Class II device regulated under 21 CFR 868.5895. Nihon Kohden Orangemed, Inc. has at least 4 other 510(k) clearances on record.